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Few Problems Need To Consider During Re-validation Of Autoclaves

Few problems need to consider during re-validation of autoclaves
Summary: On the basis of successful of validation, there are few problems that need to be paid attention, including heat penetration, The distribution of the heat and ACE-test during re-validation.
Method:
1.Validation of instruments: After the success validation of system pressure meter and temperature meter. Conduct validation of probes under 0℃,121℃ and 115℃. If the result is compliance, the next process could be continued.
2.Methods:

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a.Heat distribution methods: As long as it is the re-validation, the test would be conducted by full load, and put the 16 probes into the chamber according to the following picture, and the normal sterilization may exist cold points, to find out the possibility of the exit of cold point, conduct the test for three times to check its reproducibility.
B. Heat penetration method: The distribution method of the probes of heat penetration is the same as a method of heat distribution, and check the heat penetration by F0 value.
C. ACE-test: Bacillus is used as a biological indicator for microbiological challenge test. Its operation is conducted at the same time with heat penetration test. Put the biological indicator into the glass bottle, and close the lid. Compare the lowest average temperature to the average temperature of the position of the indicator, and put it together with the probe. After an operation, take the indicator out of the autoclave, and get the indicator to the laboratory center, and culture in 60℃ for 48 hours, and culture another indicator that not sterilized together for positive comparison.
3.Result:
A.Sterilization system validation result: The result could meet the requirement when pressure meter, temperature meter have all been validated, and the result could meet the standard. 16 probes have been validated under 0℃, 121℃ and 115℃, and various within 0℃±0.2℃,121℃±0.3℃,115℃±0.3℃.
B.Heat penetration result: After the program enters the sterilization phase, all temperature is within 115℃-116.8℃, and could maintain for 30 min. The operation curve is as the following diagram.

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C. Heat penetration result: During heat penetration test, F0 value is in the scope of 8.92-10.90, the result could meet the requirement, heat penetration test curve is as follow:

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Heat penetration test result conclusion is as follow:

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